Heart DiseasesNCT00006192
Genetics of Coronary Artery Disease in Alaskan Natives (GOCADAN)
An observational study of Heart Diseases and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native Alaskans who are members of approximately 40 families. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Diseases, Cardiovascular Diseases, Atherosclerosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2000to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native Alaskans who are members of approximately 40 families.
Read the detailed description
BACKGROUND:
There are many compelling reasons to study heart disease in the Native Alaskans. These Eskimo villages are remote and isolated. The traditional lifestyle is being eroded by mechanization and a westernized diet. There has been relatively little outside genetic influence and they are, like the American Indians of the lower 48 states, beginning to show a marked acceleration in the prevalence of atherosclerosis and coronary artery disease.
DESIGN NARRATIVE:
The study is a family-based, cross sectional study. Recognized and emerging risk factors and prevalent cardiovascular disease are documented in each individual through a standardized interview, physical exam, laboratory measurements, carotid ultrasound, ECG, and a review of centralized medical records. Assays will be made of contemporary samples and serum specimens stored at the Anchorage Center CDC antedating this study (10 to 20 years ago) for specific markers of inflammation and serologic responses. Through a ten-centimorgan genetic map, attempts will be made to find specific genes that relate to cardiovascular disease.
The study uses standard methods to assess risk factors relating to lipid metabolism, hypertension, and diabetes mellitus. Importantly, the study also uses state-of-the-art methods for detection of infectious disease exposure, specifically to C. pneumoniae, cytomegalovirus, and other infectious agents hypothesized to play a role in atherogenesis. A case-control age-matched design is used to analyze the infectious disease burden.
- Conditions
- Heart Diseases, Cardiovascular Diseases, Atherosclerosis, Hypertension, Diabetes Mellitus, Coronary Arteriosclerosis
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, Atherosclerosis, Hypertension, Diabetes Mellitus, Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2000 (estimated)
- Study startAug 2000
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Giacomo Ruotolo, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006192
- Sponsor's protocol ID
- 910
- Other IDs
- U01HL064244
- Status last verified
- May 2009
- First submitted
- 31 Aug 2000
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Nobmann ED, Ponce R, Mattil C, Devereux R, Dyke B, Ebbesson SO, Laston S, MacCluer J, Robbins D, Romenesko T, Ruotolo G, Wenger CR, Howard BV; GOCADAN study, 2000-2003. Dietary intakes vary with age among Eskimo adults of Northwest Alaska in the GOCADAN study, 2000-2003. J Nutr. 2005 Apr;135(4):856-62. doi: 10.1093/jn/135.4.856.
PubMed 15795447Howard BV, Devereux RB, Cole SA, Davidson M, Dyke B, Ebbesson SO, Epstein SE, Robinson DR, Jarvis B, Kaufman DJ, Laston S, MacCluer JW, Okin PM, Roman MJ, Romenesko T, Ruotolo G, Swenson M, Wenger CR, Williams-Blangero S, Zhu J, Saccheus C, Fabsitz RR, Robbins DC. A genetic and epidemiologic study of cardiovascular disease in Alaska natives (GOCADAN): design and methods. Int J Circumpolar Health. 2005 Jun;64(3):206-21. doi: 10.3402/ijch.v64i3.17985.
PubMed 16050315Carter EA, MacCluer JW, Dyke B, Howard BV, Devereux RB, Ebbesson SO, Resnick HE. Diabetes mellitus and impaired fasting glucose in Alaska Eskimos: the Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN) study. Diabetologia. 2006 Jan;49(1):29-35. doi: 10.1007/s00125-005-0071-9. Epub 2005 Dec 21.
PubMed 16369773Voruganti VS, Cole SA, Ebbesson SO, Goring HH, Haack K, Laston S, Wenger CR, Tejero ME, Devereux RB, Fabsitz RR, MacCluer JW, Umans JG, Howard BV, Comuzzie AG. Genetic variation in APOJ, LPL, and TNFRSF10B affects plasma fatty acid distribution in Alaskan Eskimos. Am J Clin Nutr. 2010 Jun;91(6):1574-83. doi: 10.3945/ajcn.2009.28927. Epub 2010 Apr 21.
PubMed 20410100
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Coronary Artery Disease in Alaskan Natives (GOCADAN)
- ClinicalTrials.gov ID
- NCT00006192
- Acronym / sponsor ID
- 910
- Conditions
- Heart Diseases, Cardiovascular Diseases, Atherosclerosis, Hypertension, Diabetes Mellitus, Coronary Arteriosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 2000
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 1 Sep 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native Alaskans who are members of approximately 40 families.
Detailed description
BACKGROUND:
There are many compelling reasons to study heart disease in the Native Alaskans. These Eskimo villages are remote and isolated. The traditional lifestyle is being eroded by mechanization and a westernized diet. There has been relatively little outside genetic influence and they are, like the American Indians of the lower 48 states, beginning to show a marked acceleration in the prevalence of atherosclerosis and coronary artery disease.
DESIGN NARRATIVE:
The study is a family-based, cross sectional study. Recognized and emerging risk factors and prevalent cardiovascular disease are documented in each individual through a standardized interview, physical exam, laboratory measurements, carotid ultrasound, ECG, and a review of centralized medical records. Assays will be made of contemporary samples and serum specimens stored at the Anchorage Center CDC antedating this study (10 to 20 years ago) for specific markers of inflammation and serologic responses. Through a ten-centimorgan genetic map, attempts will be made to find specific genes that relate to cardiovascular disease.
The study uses standard methods to assess risk factors relating to lipid metabolism, hypertension, and diabetes mellitus. Importantly, the study also uses state-of-the-art methods for detection of infectious disease exposure, specifically to C. pneumoniae, cytomegalovirus, and other infectious agents hypothesized to play a role in atherogenesis. A case-control age-matched design is used to analyze the infectious disease burden.
Study design
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Background: PubMed 15795447Nobmann ED, Ponce R, Mattil C, Devereux R, Dyke B, Ebbesson SO, Laston S, MacCluer J, Robbins D, Romenesko T, Ruotolo G, Wenger CR, Howard BV; GOCADAN study, 2000-2003. Dietary intakes vary with age among Eskimo adults of Northwest Alaska in the GOCADAN study, 2000-2003. J Nutr. 2005 Apr;135(4):856-62. doi: 10.1093/jn/135.4.856.
- Background: PubMed 16050315Howard BV, Devereux RB, Cole SA, Davidson M, Dyke B, Ebbesson SO, Epstein SE, Robinson DR, Jarvis B, Kaufman DJ, Laston S, MacCluer JW, Okin PM, Roman MJ, Romenesko T, Ruotolo G, Swenson M, Wenger CR, Williams-Blangero S, Zhu J, Saccheus C, Fabsitz RR, Robbins DC. A genetic and epidemiologic study of cardiovascular disease in Alaska natives (GOCADAN): design and methods. Int J Circumpolar Health. 2005 Jun;64(3):206-21. doi: 10.3402/ijch.v64i3.17985.
- Background: PubMed 16369773Carter EA, MacCluer JW, Dyke B, Howard BV, Devereux RB, Ebbesson SO, Resnick HE. Diabetes mellitus and impaired fasting glucose in Alaska Eskimos: the Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN) study. Diabetologia. 2006 Jan;49(1):29-35. doi: 10.1007/s00125-005-0071-9. Epub 2005 Dec 21.
- Derived from this study: PubMed 20410100Voruganti VS, Cole SA, Ebbesson SO, Goring HH, Haack K, Laston S, Wenger CR, Tejero ME, Devereux RB, Fabsitz RR, MacCluer JW, Umans JG, Howard BV, Comuzzie AG. Genetic variation in APOJ, LPL, and TNFRSF10B affects plasma fatty acid distribution in Alaskan Eskimos. Am J Clin Nutr. 2010 Jun;91(6):1574-83. doi: 10.3945/ajcn.2009.28927. Epub 2010 Apr 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Ruotolo
Medstar Health Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006192, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.